Tearing of Membranes Before Birth - a Comparison Between Two Ways of Induction of Labor Pitocin Opposite Prostaglandin

NCT02720978 | Unknown Phase 3

• 1 other identifier: 0073-15-TLV
• Study Type: interventional
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Premature rupture of membranes (PROM) is a common occurrence that occurs in the incidence of 8-10% of births. Since the duration until delivery is important in avoiding the risk of complications, several studies have been performed in order to understand what is the preferred way to manage this condition of PROM in women that are not in active labor. In the largest random study that has been performed 20 years ago, there was found an advantage for labor induction with oxytocin over labor induction with Prostaglandin or waiting. However, the most important component - the BISHOP score, that affects the decision of the labor induction way, was not reported and was not taken into consideration.

Conditions

Fetus or Newborn or Maternal; Effects of Induction of Labor

Outcome Measures

Primary Outcomes (1)

• The duration from the beginning of labor induction until delivery

  5 days

Secondary Outcomes (1)

• Duration of labor induction from rupture of membranes until delivery.

  5 days

Study Arms (2)

Intravenous oxytocin

EXPERIMENTAL

Women that arrive to women's ER and diagnosed with rupture of membranes in week 34+0 and onward, are not in active labor and with Bishop score lower than 7. Those who agreed to participate in the study after signing an informed consent form will undergo the following steps: 1. Verification rupture of membranes and gestational age. 2. Choosing the treatment group Intravenous oxytocin from red envelope, randomly. 3. Collecting basic and obstetric data, laboratory results and physical examination, monitoring and sonar. 4. Induction according to departmental protocol of each delivery way. 5. Data collecting after the delivery.

Drug: Intravenous oxytocin

vaginal prostaglandin

EXPERIMENTAL

Women that arrive to women's ER and diagnosed with rupture of membranes in week 34+0 and onward, are not in active labor and with Bishop score lower than 7. Those who agreed to participate in the study after signing an informed consent form will undergo the following steps: 1. Verification rupture of membranes and gestational age. 2. Choosing the treatment group vaginal prostaglandin from red envelope, randomly. 3. Collecting basic and obstetric data, laboratory results and physical examination, monitoring and sonar. 4. Induction according to departmental protocol of each delivery way. 5. Data collecting after the delivery.

Drug: vaginal prostaglandin

Interventions

Intravenous oxytocin DRUG

Intravenous oxytocin chosen randomly. we will collect basic and obstetric data, laboratory results and physical examination, monitoring and sonar. Induction according to departmental protocol of each delivery way. Data collecting after the delivery.

Intravenous oxytocin

vaginal prostaglandin DRUG

Vaginal prostaglandin chosen randomly. we will collect basic and obstetric data, laboratory results and physical examination, monitoring and sonar. Induction according to departmental protocol of each delivery way. Data collecting after the delivery.

vaginal prostaglandin

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• rupture of membranes in BISHOP score lower than 7.
• Pregnancy week 34+0 and onward.
• Singleton pregnancy.
• Verifying fetal monitoring.
• Normal maternal temperature (lower than 37.8)
• Without vaginal bleeding or suspected placental separation
• Contractions in frequency of less than 3 in 10 minutes
• Signed consent form.

You may not qualify if:

• Multiple pregnancy.
• Maternal age below 18 or over 42.
• Active labor
• Contractions in frequency of more than 3 in 10 minutes or cervical dilation ≥2 cm.
• Lack of consent to participate in the study

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Officials

• Sharon Maslovitz, MD

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: March 28, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 26, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share